This study compares the proportion of women of color versus non-women of color to assess the coronavirus disease of 2019 (COVID-19) related financial hardship and distress in those who decline tomosynthesis mammographic imaging screening trial (TMIST) participation. This study may find out which factors may lead women of color to decline participation in EA1151 (TMIST).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05076266.
PRIMARY OBJECTIVE:
I. In a population of women who decline participation in TMIST (EAQ201 participants), compare the proportion of women of color (WOC) versus (vs) non-WOC with respect to who experience COVID-related financial hardship, a composite endpoint defined as any psychological response (financial distress, food/housing insecurity) or change in their material condition.
SECONDARY OBJECTIVES:
I. Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-related change in their material condition, a composite measure.
II. Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-specific perceived financial distress.
III. Compare the proportion of WOC in TMIST participants vs EAQ201 participants.
EXPLORATORY OBJECTIVES:
I. Compare the proportion of WOC vs non-WOC EAQ201 participants with COVID-related employment change, a composite measure.
II. Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-specific perceived distress and perceived susceptibility to COVID and breast cancer.
III. Compare the proportions of WOC vs non-WOC EAQ201 participants with relative increase in smoking and alcohol use, risk factors for breast cancer.
IV. Compare participant-reported quality of life, anxiety and depression between WOC and non-WOC EAQ201 participants.
V. Assess the effects of sociodemographic characteristics, and federal-, state- or local-level COVID-19 factors on TMIST participation, in WOC vs non-WOC.
OUTLINE:
Participants complete a survey on study.
Trial PhasePhase III
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationECOG-ACRIN Cancer Research Group
Principal InvestigatorRuth C Carlos
